NCT06899243

Efficacy of CL22205 on Bone Mineral Density and Menopausal Symptoms

The Effect of CL22205 on Bone Mineral Density and Menopausal Symptoms in Women: A Randomized, Double-blind, Placebo Controlled Clinical Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Eetho Brands, Inc · Industry
• Sex: Female
• Age: 55 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the effect of CL22205 on bone mineral density and menopausal symptoms in women.

Detailed description

A total of 80 healthy female subjects aged between 55 and 65 years will be included in the study. Assessment of inclusion and exclusion criteria will be done based on clinical and laboratory investigations. The eligible subjects will be randomized as per the computer-generated randomization list. The subjects will be assigned to either CL22205 - 200 mg or placebo arms at 1:1 ratio. The subjects will be instructed to take one capsule a day after breakfast for 360 days. Apart from primary and secondary outcomes, the study will also record the vital signs and adverse events to evaluate the herbal composition's safety and tolerability. The safety assessment of the CL22205 will also include routine laboratory investigations on blood, urine and clinical chemistry at screening and the final visit of the intervention.

Conditions

• Menopausal Symptoms

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	CL22205	200 mg, Route : Oral, One capsule a day after breakfast for 360 days
OTHER	Placebo	Route : Oral, One capsule a day after breakfast for 360 days

Timeline

• Start date: 2025-03-25
• Primary completion: 2026-05-10
• Completion: 2026-08-30
• First posted: 2025-03-27
• Last updated: 2025-03-27